Investigating the effects of TTS-fentanyl for cancer pain on the psychological status of patients naïve to strong opioids: an open label study.

Few studies have investigated the effect of fentanyl delivered via the transdermal route with regard to the patient's psychological status. Patients who were naive to strong opioids and were attending a palliative care unit for pain relief from advanced cancer participated in this study to determine the effect of transdermal therapeutic system fentanyl (TTS-F) on their psychological condition. Spielberger State-Trait Anxiety Inventory (STAI), Zung Self-Rating Depression Scale (SDS), the Karnofsky Performance Scale (100-0, optimum-death), and a Visual Analogue Scale (VAS) (0: no pain; 10: worst pain) were used to measure the level of pain. Data were collected at baseline (T0), on the 7th day (T1), and on the 14th day (T2) of TTS-F application in order to determine changes in correlation to TTS-F dose. Patients' status improved according to the Zung SDS questionnaire (P < .0005) and with each of its subscales (P < .05). A similar improvement was observed according to the Spielberger STAI questionnaire (P = .002). Moreover, VAS measures demonstrated that patients achieved significant pain relief (P < .0005), while patients' performance status did not alter significantly over the study period. Furthermore, the Zung SDS showed a statistically significant correlation when compared with the Spielberger STAI (P < .01). These data provide some evidence that the psychological status, as measured with respect to depression and anxiety in patients with advanced cancer, is improved in patients receiving TTS-fentanyl. Future research should use a broad range of psychological measurements in order to assist the development of practices, which are aimed at the improvement of quality of life in these patients.

Pain management of cancer patients with transdermal fentanyl: a study of 1828 step I, II, & III transfers.

UNLABELLED: The aim of this observational study was to examine pain management outcomes and quality of life (QoL) measures in cancer patients with intolerable or chronic severe pain transferring from World Health Organization's step I, II, and III analgesics to the transdermal therapeutic fentanyl system (TTS-F). This study examines the safety and efficacy of TTS-F in long-term pain management, addressing the role of TTS-F in cancer pain. Pain measures were assessed in 1828 patients (step I [naïve], 268; step II [codeine], 1239; and step III [morphine], 321) on the basis of selected questions from the Greek-Brief Pain Inventory. Overall treatment satisfaction (scale, 1 to 4), QoL, and European Collaborative Oncology Group (ECOG) status were also recorded. These were assessed in relation to TTS-F dose, stratified by transfer step, primary cancer, metastases, type of pain, and concomitant use of anti-inflammatory drugs. Of 1828 patients, 100 (5.5%) withdrew, and an addition 14 (0.8%) discontinued because of side effects. A total of 1714 continued on study; 744 patients died, and 970 departed during the study period. In total, 93.8% were satisfied with their pain relief, and complete patient satisfaction was obtained within 2 months. Pain, QoL, and treatment satisfaction measures demonstrated statistically significant improvements over time, independent of the step transfer. Although doses of TTS-F were higher for step III > II > I and for metastatic than nonmetastatic, the median dose for all groups remained 50 microg/h throughout the study period. Pain and QoL improvements were independent of patient characteristic(s). Direct transfer to TTS-F for patients with intolerable or chronic moderate to severe cancer pain offers an efficient and safe long-term analgesic option for palliative care patients. Careful selection and follow-up by experienced palliative care specialists are mandatory. TTS-F as a first-line analgesic approach for severe cancer pain should be considered a viable option because of its durable efficacy and low incidences of side effects. PERSPECTIVE: At a fairly constant dose of 50 microg/h, the transdermal therapeutic fentanyl system offers a safe, well-tolerated pain relief treatment for carefully monitored patients with cancer pain. The authors stress that this includes patients who experience difficulties in their pain management while progressing through the WHO's ladder for pain management.

Long-term management of noncancer pain with transdermal therapeutic system-fentanyl.

Transdermal therapeutic system-fentanyl (TTS-F) has been extensively studied in cancer pain management. However, few studies have addressed the long-term management of noncancer pain, especially when it relates to neuropathic pain. A total of 529 patients were recruited into this prospective open-label study to determine the safety and effectiveness of TTS-F in relation to quality-of-life (QOL) stratified according to pain type and etiology. TTS-F significantly improves QOL within 28 days, and pain management within 48 hours. The frequency of side effects rapidly decreases over time, and patients not experiencing adequate pain management are identified within 28 days. The median duration of therapy for effective pain management was 10 months, and 90% of patients sustained such efficacy. TTS-F offers statistically significant increases in QOL-Short Form 12 (including the Physical Component Scale and Mental Component Scale measures) and pain control (Greek Brief Pain Inventory) from one time point to the next (P <.0001). These improvements are not influenced by pain type or etiology. TTS-F is a safe and effective pain management system independent of patient characteristics and demographic factors. What is of most importance is that in those patients with neuropathic pain, for whom opioids have long been thought to be ineffective, similar effectiveness is demonstrated when compared to patients with nociceptive pain.

Long-term cancer pain management in morphine pre-treated and opioid naive patients with transdermal fentanyl.

There is emerging data supporting the use of TTS-F (transdermal therapeutic system-fentanyl) in opioid naive patients. Our study examines the safety and efficacy of TTS-F in the long-term control of cancer pain in opioid naive patients and those transferring from oral morphine. Pain was assessed in 589 patients (Group A: 268 opioid naive, Group B: 321 transferring from morphine) using a Visual Analogue Scale (VAS; 0-10), based on selected questions from the Greek Brief Pain Inventory (GBPI). Overall treatment satisfaction was assessed on a 4-point scale. Quality of Life (QOL) and ECOG (0-4) status were also recorded. These were assessed in relation to TTS-F dose, pain type (neuropathic, combined, nociceptive), concomitant use of anti-inflammatory drugs and other demographic data. Of 589 patients, 59 (10%) withdrew as a result of inadequate pain satisfaction or for other reasons. There were no discontinuations due to side effects; no Grade 3-4 events occurred. A total of 530 continued on-study, 211 patients died during study period and 295 departed; all (506; 89%) were satisfied with their pain relief. Analysis of patients at baseline, 28 days, 6 and 12 month time points (n = 153 Group A; n = 214 Group B) with respect to QOL and pain measures indicated a statistically significant (p < 0.001) improvement in all measures across time independent of pain type, or any other patient characteristic(s). In patients with intolerable pain, transfer to TTS-F offers an efficient and safe long-term analgesic option. TTS-F offers durable long-term maintenance of pain relief with acceptable side effects in opioid naive patients. In general, TTS-F as a first line analgesic approach for carefully selected and monitored patients experiencing moderate to severe cancer pain should be considered.

Nurses' attitudes toward truthful communication with patients with cancer. A Greek study.

The purpose of this study was to examine Greek nurses' attitudes toward truth-telling practices when working with cancer patients and their psychological status regarding the difficulties they face in their day-to-day communication with these patients. A self-administered questionnaire composed of 19 questions, including both multi-item scales and single-item measures, was designed for the study. For this study, 200 nurses were asked to participate, of whom 148 (74%) completed and returned the questionnaire. The questionnaire is self-administered, formulated after a thorough review of the relevant literature. The pretesting was carried out using the alpha model of reliability and the Cochran Chi Square test (Q-test), which was 545.46 (P < .0001) and showed a Cronbach alpha coefficient of 0.7148. A large percentage of the respondents (75.7%) believe that only some patients with cancer should be told the truth of their diagnosis and prognosis, although a larger percentage (89.1%) believe that the truth should be told to the relatives. Most of the respondents (66.2%) reported that is difficult to engage in open communication with the patients, because their academic education did not sufficiently train them in communication skills. Although 83.78% of the nurse respondents do not reveal that the disease is incurable, 86 (58.1%) believe that only the patient's physician should reveal the truth. These results indicate that although many Greek nurses believe that the patients should be informed and know their condition, lack of training in communication skills is a major obstacle to achieving this. Finally, this self-assessment questionnaire may provide acceptable and valid assessment of Greek nurses' perceptions and attitudes on truth telling.

Greek McGill Pain Questionnaire: validation and utility in cancer patients.

In 1968, Melzack and Casey suggested that there are three major psychological dimensions of pain: sensory, affect, evaluative. These categories interact with one another to provide quantitative and qualitative information on the components of pain. In 1975, Melzack developed the McGill Pain Questionnaire, which is composed of four major parts and evaluates the qualities of pain. The aim of this study was to assess the applicability, reliability, and validity of the McGill Pain Questionnaire on a sample of Greek cancer patients receiving palliative treatment. It was administered to 114 cancer patients before the initiation of the palliative treatment, and then to 80 cancer patients during the treatment 7 days later. The results indicated that scale reliability was very good (0.95-0.97). During the pretreatment period, correlations between Present Rating Index (PRI), Present Pain Intensity (PPI), and Number of Words Chosen (NWC) ranged between 0.42 and 0.92. During the post-treatment time, the correlations ranged between 0.28 and 0.91. Only 21.8% of the words met a criterion of 30% for representativeness on the first administration of the questionnaire, and 9% met this criterion on the second. Validity was satisfactory (P < 0.005) according to "responsiveness to changes in time", as there was a statistical difference between the pretreatment and post-treatment time. Patients presented a desirable level of convergent construct validity (P < 0.05) concerning their performance status. Exploratory factor analysis was examined and two factors with eigenvalue over 1 were extracted, and they accounted for 95.2% of the variance. These results support the Greek-MPQ as a reliable and valid measure for evaluating the qualities of cancer pain in patients receiving palliative care.

Comparison of octreotide administration vs conservative treatment in the management of inoperable bowel obstruction in patients with far advanced cancer: a randomized, double- blind, controlled clinical trial.

BACKGROUND: Conservative treatment of inoperable bowel obstruction in terminal cancer patients has been found to be effective in controlling the distressing symptoms caused by this complication. The purpose of this study was to evaluate the efficacy of octreotide in the management of nausea, vomiting and abdominal pain, secondary to bowel obstruction in terminally ill cancerpatients, when surgery was inappropriate. PATIENTS AND METHODS: Sixty-eight terminally ill cancer patients participated in the study (age range 42-77 years, 36 male, 32 female). The primary cancer location was in the gastrointestinal system, the abdomen and the pelvis. The survival time ranged from 7 to 61 days. Diagnosis was made on clinical grounds and confirmed by plain abdominal radiography. The patients were randomly assigned into two equal groups, A (N=34) and B (N=34). Group A received, by continuous subcutaneous (c.sc.) administration with a pump: hyoscine butylbromide 60-80mg/day and chlorpromazine (15-25 mg/day); group B received octreotide 600-800 microg/day and chlorpromazine (15-25 mg/day). As an opioid, patients received either a low-dose of morphine (1,530mg/day) in continuous subcutaneous administration or TTS Fentanyl (25-75 microg/hour). Diary cards were used to monitor vomiting. nausea, pain intensity, anorexia and fatigue. The symptoms were assessed at T1-baseline, T2 and T3-third and sixth day of treatment, respectively, and T4- one day before death. RESULTS: Data analysis showed there were statistically significant differences between the two groups: a) in vomiting and nausea in relation to percentage change from T1 to T2 and b) in fatigue and anorexia in relation to symptom improvement at T1 to T2, T1 to T3 and T1 to T4 (p<0.05), while in pain there was no statistically significant difference between the two groups in relation to percentage change from T1 to T2, T1 to T3 and T1 to T4. CONCLUSION: The administration of octreotide, in combination with traditional pharmacological treatment, can be very effective in the symptom management of inoperable bowel obstruction in terminal cancerpatients

Use of TTS fentanyl as a single opioid for cancer pain relief: a safety and efficacy clinical trial in patients naive to mild or strong opioids.

BACKGROUND: Up to now, a transdermal therapeutic system (TTS) of fentanyl has been applied to cancer patients on opioid analgesics previously treated with mild opioids or morphine. The aim of this study was to investigate the efficacy and safety of TTS fentanyl (patch) administration as an analgesic to patients treated with opioid analgesics for moderate-to-severe cancer pain, with immediate-release oral morphine only as rescue medication. The prior analgesic medication of the patients did not include mild or strong opioids. METHODS: The study group consisted of 113 patients (54 men and 59 women; age range: 21-87 years, mean +/- SD 61.3 +/- 14.84 years) with undertreated chronic cancer pain. The study period was 42 days. The patients were hospitalized for the first 3 days of the study; thereafter they were transferred to their home for the rest of the study. Daily cards were completed, noting their pain score (0-10 VAS), nausea, vomiting, constipation, skin reactions, dizziness or any other complaints. Vital signs were also recorded. Data assessments were made at baseline, on days 1, 2 and 3 (during hospitalization) and thereafter on days 7, 14, 21, 28, 35, and 42 after hospital discharge. The initial TTS fentanyl delivery rate was chosen depending on the patient's analgesic requirements. All patients were given an oral morphine solution (5-10 mg), every 4-6 h, for the first 12 h, as rescue medication. RESULTS: Baseline pain score was between 6 and 10 (mean +/- SD 7.1 +/- 1.7). The initial TTS fentanyl delivery rate was between 25 and 50 microg/h (mean +/- SD 36.5 +/- 15.7). On day 3, 95 patients (84%) reported a pain score < or = 3 (mean +/- SD 0.5 +/- 0.8), 14 patients (12.4%) a pain score of 4 and 4 patients (3.5%) of 5-8. No adverse effects suggesting the discontinuation of the study were reported. From day 7 until the completion of the study, the mean pain score was between 1.3 and 0.16 while the TTS fentanyl delivery rate on day 42 was between 25 and 400 microg/h (mean +/- SD 122.1 +/- 81.2 microg/h). CONCLUSION: Analgesic treatment with TTS fentanyl used as a single opioid is effective and safe for cancer pain relief, given that is cautiously applied, in patients requiring strong opioid analgesics even if they were naive to strong or mild opioids.